Y-Mabs Therapeutics Stock Price, News & Analysis

Y-mAbs Therapeutics (Nasdaq: YMAB) reported its Q2 2021 financial results, highlighting a net loss of $22.9 million, or ($0.53) per share, a reduction from the $40.4 million loss in Q2 2020. Revenues totaled $11.0 million, driven by $9.0 million from DANYELZA sales. The company had a cash balance of $233.6 million at the end of the quarter, significantly up from $114.6 million at the end of 2020. Y-mAbs is progressing with multiple regulatory submissions, including an accepted BLA submission for DANYELZA in China and an anticipated BLA resubmission for omburtamab by year-end.

Y-mAbs Therapeutics (Nasdaq: YMAB) will report its financial results for Q2 2021 on August 5, 2021, post-market close. This will be followed by a conference call on August 6, 2021, at 9 a.m. ET. Key participants include founder Thomas Gad, CEO Dr. Claus Moller, and CFO Bo Kruse. The company focuses on innovative antibody-based cancer therapies and has an FDA-approved product, DANYELZA, along with a pivotal-stage candidate, omburtamab.

Y-mAbs Therapeutics (NASDAQ: YMAB) announced that SciClone Pharmaceuticals has submitted a Biologics License Application (BLA) for DANYELZA® (naxitamab-gqgk) to China's National Medical Products Administration (NMPA) for treating relapsed/refractory high-risk neuroblastoma. This submission follows FDA approval within just seven months, indicating rapid progress in making the innovative therapy available to pediatric patients in China. Y-mAbs emphasizes the strategic collaboration with SciClone to ensure timely market entry if approved.

Y-mAbs Therapeutics (Nasdaq: YMAB) announced a positive opinion from the EMA's Committee for Orphan Medicinal Products for ¹⁷⁷Lu-omburtamab-DTPA, targeting medulloblastoma. This recommendation supports orphan drug designation, expected to be granted by the European Commission within 30 days. The designation will provide development incentives and 10 years of market exclusivity upon approval, enhancing Y-mAbs' European expansion plans. The company aims to improve treatment options for patients with this rare and life-threatening condition.

Y-mAbs Therapeutics (Nasdaq: YMAB) announced the conclusion of a Type B meeting with the FDA regarding its drug omburtamab for treating pediatric neuroblastoma patients with CNS/metastatic conditions. The company believes it gained clarity on resubmitting the Biologics License Application (BLA) after discussing statistical analysis plans. Y-mAbs plans to provide additional data to the FDA in Q3 2021 and aims for a rolling BLA resubmission by year-end. The approval of omburtamab could fulfill an unmet medical need in pediatric oncology.

Y-mAbs Therapeutics, focused on innovative cancer treatments, announced the presentation of three-year follow-up data for DANYELZA and GM-CSF in high-risk neuroblastoma patients at the ASCO Virtual Annual Meeting on June 4, 2021. The study included 73 patients, showing a three-year event-free survival of 74% for first complete remission and 19% for later remissions. Overall survival rates were 92% and 66%, respectively. The positive data suggests DANYELZA's potential to differentiate itself from existing therapies if approved.

Y-mAbs Therapeutics (Nasdaq: YMAB) announced interim results from a phase 1 dose-escalation study for omburtamab targeting diffuse intrinsic pontine glioma (DIPG) at the ASCO Virtual Annual Meeting on June 4, 2021. The study demonstrated good tolerability with a median overall survival improvement of 3-4 months over historical controls. The company plans to advance this promising candidate into a phase 2 study later this year, further expanding the omburtamab franchise to include other CNS tumors. The study's positive data marks a significant step in addressing an unmet medical need in cancer treatment.

Y-mAbs Therapeutics announced an exclusive distribution agreement with Adium Pharma for Latin America, covering DANYELZA® and the investigational drug omburtamab. DANYELZA, approved by the FDA in 2020, targets high-risk neuroblastoma in pediatric patients. Omburtamab is pending approval for CNS metastasis treatment. The agreement grants Adium distribution rights in 18 countries, enhancing market access. Y-mAbs aims to submit further applications for omburtamab by late Q2 or early Q3 2021. Financial terms were not disclosed.

Y-mAbs Therapeutics announced a presentation by Dr. Nai-Kong V. Cheung at the PEGS Boston Virtual Conference on May 13, 2021, focusing on their SADA technology platform for cancer treatment. The SADA technology aims to enhance the therapeutic index in radioimmunotherapy, potentially improving treatment outcomes while minimizing toxicity. Y-mAbs is a biopharmaceutical company with a strong pipeline, including the FDA-approved DANYELZA® and the pivotal-stage candidate omburtamab. The technology is exclusively licensed from Memorial Sloan Kettering Cancer Center and MIT.